Senior Quality Assurance Specialist - QA Compliance, Stevenage
Client:
Location:
Job Category:
Other EU work permit required:
Yes Job Reference:
0d24a93afc34 Job Views:
54 Posted:
22.01.2025 Expiry Date:
08.03.2025 Job Description:
Role Summary The post holder will work in the Product Delivery Quality Assurance team, supporting the delivery of autologous CAR T-cell products in compliance with Good Manufacturing (GMP). The role will be based in Stevenage. Key Responsibilities Maintaining the requirements of Good Manufacturing Practice in a multi-product facility delivering cell and gene therapies. Control of record forms for use in production and QC, applying batch or test article identity traceability features and maintaining an audit trail of issue, use, reconciliation, and archiving. Preparation, checking, and issue of in-process and Drug Product labels, ensuring compliance with the authorised template and the batch-specific/patient-specific data thus maintaining product traceability and regulatory compliance. Review of Batch Manufacturing Records and Quality Control records and escalation of quality issues. Authoring, approval, and review of GxP documentation. Supplier management: Assessment and qualification (or disqualification) of raw material suppliers, including audits; Audits of GMP contractors conducting outsourced activities; and Risk Job assessments. Materials review and release for use in Production and QC, ensuring that only approved suppliers and materials are available. Management of the Pharmaceutical Quality System (PQS) including coordinating change controls, deviations, microbiological out-of-trend and out-of-specification results and other environmental excursions. Continuous improvement. Process and equipment qualification and validation. Analytical and Quality Control assay validation. First point of escalation issues and communication to QPs. Collation and trending of Quality KPIs. Support Product Quality Review. Conducting internal audits as lead auditor in accordance with a defined schedule in a supporting capacity. Support regulatory inspections - backroom support and/or SME support. Line management of Junior Quality Assurance colleagues. Demonstrated skills and competencies E – Essential P – Preferred Experience • 2-5 years’ experience (ideally industrial) in equivalent roles, with responsibility for quality assurance in a pharmaceutical or equivalent quality management system. • Experience with MHRA (E) and HTA (P) inspections, either as host or involved contract giver to a manufacturing site. Qualifications • BSc in pharmaceutical sciences, immunology or equivalent experience (E) • MSc in pharmaceutical sciences, immunology or equivalent experience (P) Skills/Specialist knowledge • GMP & GCP principles. • Manufacturing and testing procedures for advanced therapies. • The basis of CAR T-cell technology. • Good communication skills and ability to motivate colleagues. • Ability to build strong collaborative cross-departmental relationships. • Skills to work within a team, understanding his/her responsibilities and delegating to others and remain accountable for his/her work. • The ability to work independently to a high standard with minimal direction from a manager. Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.
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Client:
Location:
Job Category:
Other EU work permit required:
Yes Job Reference:
0d24a93afc34 Job Views:
54 Posted:
22.01.2025 Expiry Date:
08.03.2025 Job Description:
Role Summary The post holder will work in the Product Delivery Quality Assurance team, supporting the delivery of autologous CAR T-cell products in compliance with Good Manufacturing (GMP). The role will be based in Stevenage. Key Responsibilities Maintaining the requirements of Good Manufacturing Practice in a multi-product facility delivering cell and gene therapies. Control of record forms for use in production and QC, applying batch or test article identity traceability features and maintaining an audit trail of issue, use, reconciliation, and archiving. Preparation, checking, and issue of in-process and Drug Product labels, ensuring compliance with the authorised template and the batch-specific/patient-specific data thus maintaining product traceability and regulatory compliance. Review of Batch Manufacturing Records and Quality Control records and escalation of quality issues. Authoring, approval, and review of GxP documentation. Supplier management: Assessment and qualification (or disqualification) of raw material suppliers, including audits; Audits of GMP contractors conducting outsourced activities; and Risk Job assessments. Materials review and release for use in Production and QC, ensuring that only approved suppliers and materials are available. Management of the Pharmaceutical Quality System (PQS) including coordinating change controls, deviations, microbiological out-of-trend and out-of-specification results and other environmental excursions. Continuous improvement. Process and equipment qualification and validation. Analytical and Quality Control assay validation. First point of escalation issues and communication to QPs. Collation and trending of Quality KPIs. Support Product Quality Review. Conducting internal audits as lead auditor in accordance with a defined schedule in a supporting capacity. Support regulatory inspections - backroom support and/or SME support. Line management of Junior Quality Assurance colleagues. Demonstrated skills and competencies E – Essential P – Preferred Experience • 2-5 years’ experience (ideally industrial) in equivalent roles, with responsibility for quality assurance in a pharmaceutical or equivalent quality management system. • Experience with MHRA (E) and HTA (P) inspections, either as host or involved contract giver to a manufacturing site. Qualifications • BSc in pharmaceutical sciences, immunology or equivalent experience (E) • MSc in pharmaceutical sciences, immunology or equivalent experience (P) Skills/Specialist knowledge • GMP & GCP principles. • Manufacturing and testing procedures for advanced therapies. • The basis of CAR T-cell technology. • Good communication skills and ability to motivate colleagues. • Ability to build strong collaborative cross-departmental relationships. • Skills to work within a team, understanding his/her responsibilities and delegating to others and remain accountable for his/her work. • The ability to work independently to a high standard with minimal direction from a manager. Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.
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